01
Define Scope
Every engagement begins by understanding your medical device, connected technologies, software version, and intended use. This allows us to build a test plan that reflects your actual product.
FDA Medical Device Security Testing Services
From embedded software to cloud services, we test every attack surface that could affect your medical device and FDA submission.
Talk to an Expert
Fortune 100 to startup we secure them all
DEFINITION
What Is FDA Medical Device Security Testing?
FDA medical device security testing is an independent security assessment carried out on connected medical devices and their supporting systems.
FDA medical device security testing is an independent security assessment carried out on connected medical devices and their supporting systems. The goal is to uncover weaknesses that attackers could exploit, verify that security protections work as intended, and produce evidence that supports FDA cybersecurity submissions.
Vulnerabilities
Vulnerabilities We Identify
We uncover weaknesses that could compromise device security and safety.
01
Insecure Authentication
02
Broken Access Control
03
Insecure APIs
04
Firmware Vulnerabilities
05
Hardcoded Credentials
06
Insecure Wireless Communication
07
Sensitive Data Exposure
08
Insecure Data Storage
09
Privilege Escalation
Process
Our FDA Medical Device Security Testing Process
A practical testing process designed around your device, its architecture, and FDA cybersecurity expectations.
02
Device Architecture Review
Before testing starts, we examine how every component communicates. This helps us recognise trust boundaries, critical assets, and locations where an attacker could gain access.
03
Threat Modeling
Rather than testing everything equally, we focus on the risks that matter most. Likely attack scenarios are prioritised according to device functionality, exposure, and potential patient impact.
04
Comprehensive Security Testing
Testing is performed across the agreed scope using techniques suited to each component, whether it involves firmware, APIs, cloud services, wireless communication, or supporting applications.
05
Vulnerability Analysis and Reporting
Each confirmed finding is explained with supporting evidence, business impact, reproduction steps, and practical recommendations so your engineering team can resolve issues with confidence.
06
Remediation Validation and Retesting
Once fixes are complete, we verify that the original weakness has been removed and check that the changes have not introduced new security issues elsewhere.
Swagat Kumar Dash
Head Of Business Development
“Connect with Swagat, Your trusted penetration testing advisor. Secure your assets. Reach out Today!”
Testimonials
What Our Clients Say About Us
Read what our clients say about our services. See how Qualysec has helped several businesses to keep their digital assets safe!
“
Qualysec did a great job identifying vulnerabilities in our web and cloud applications and gave us clear steps to fix them. They stuck to deadlines, handled re-tests, and supported well.
Kenny Kim
Product Manager
Key Benefits
Benefits of FDA Medical Device Security Testing
These are the main benefits your team gains from focused medical device security testing.
Identify Critical Device Vulnerabilities
Testing reveals weaknesses in your device and connected systems before attackers find them or they create problems during FDA review.
Improve FDA Compliance Readiness
You receive clear testing records that help your team organise cybersecurity evidence and respond more effectively to FDA questions or review comments.
Enhance Patient Safety
Finding security flaws early helps prevent failures that could interrupt treatment, alter device behaviour, expose data, or affect clinical decisions.
Reduce Security and Business Risks
Early testing helps you avoid costly fixes, submission delays, product recalls, service interruptions, and damage to your company’s reputation.
Receive Actionable Remediation Guidance
Your developers receive clear explanations, supporting proof, and practical fix recommendations for every confirmed issue found during the assessment.
Build Customer and Regulatory Confidence
Independent testing shows that your company takes device security seriously and gives reviewers, partners, and healthcare buyers greater confidence.
Other Types
Types of FDA Medical Device Security Testing
Different testing approaches provide different levels of insight into your medical device's security.
Black Box Testing
Tests your medical device without internal access, revealing weaknesses an external attacker could realistically discover and exploit.
White Box Testing
Uses source code, architecture, and design information to examine deeper security flaws that external testing alone may miss.
Gray Box Testing
Combines limited internal knowledge with realistic attack techniques to evaluate security from the perspective of an authenticated user.
Free Downloads
Download Our FDA Medical Device Security Resources
Access practical resources that help you understand testing expectations, prepare documentation, and strengthen your FDA cybersecurity efforts.
FDA Medical Device Security Testing Report
See how findings, evidence, remediation guidance, and risk details are documented in a professional security testing report.
Medical Device Security Testing Methodology
Learn how our specialists plan, perform, validate, and document security testing across the complete medical device ecosystem.
FDA Cybersecurity Compliance Checklist
Review the essential cybersecurity activities and documentation commonly required before submitting a medical device for FDA review.
PRICING
FDA Medical Ddevice Penetration Testing Cost
Our Penetration Testing Service Pricing Could Save You Millions!
Process To Start Assessment
How to Begin Your FDA Medical Device Security Testing with Qualysec
Follow these steps so we can understand your device, align the scope, and begin testing with a clear plan.
1
Contact Us↗
Share a few details about your device, current development stage, expected testing needs, and planned FDA submission so we can understand what support you require.
2
Scope and Asset Collection↗
Next, you provide the relevant device versions, applications, interfaces, architecture records, and supporting systems. This gives us enough context to define an accurate testing scope.
3
Technical Consultation↗
A security specialist meets with your team to discuss the product, clarify technical questions, review risks, and agree on the testing depth needed for each component.
4
NDA and Project Approval↗
Once the scope is clear, we complete the confidentiality agreement, confirm timelines, finalise commercials, and obtain project approval before any testing activity begins.
5
Assessment Kickoff↗
Testing starts with a kickoff call covering access, contacts, communication, safety limits, evidence handling, and reporting expectations. Your team then receives a clear engagement plan.
Get a Quote
Ready to Secure Your AI/ML Models?
Reach out today to discuss your AI/ML testing needs and get a customized quote. Our cybersecurity experts will ensure that your AI systems are protected from vulnerabilities, giving you peace of mind and complete security.
0+
Total No. Of Vulnerabilities
0+
Years in Business
0+
Assessment Completed
0+
Trusted Clients
0+
Countries Served
FAQ
Frequently Asked Questions
Answers to common questions about our FDA medical device security testing services.
Medical device testing also considers patient harm and clinical performance. A standard IT test mainly focuses on systems and business data.
We can test the device itself along with its firmware and supporting software. Connected applications and cloud systems can also be included.
Yes. You can choose a focused assessment for one component or request broader testing across the complete medical device system.
We check pairing and device identity first. Testing also covers message tampering and replay attacks as well as weak encryption.
We inform your team as soon as a critical issue is confirmed. You receive enough detail to begin fixing it immediately.
Yes. Our report explains how to address each issue. Once your team completes the fixes, we test them again.
Yes, but testing must be carefully controlled. We first agree on safe limits and avoid actions that could disrupt device use.
You receive the main assessment report with evidence and fix recommendations. A separate retest report is provided after remediation.
The timeline depends on your device and selected scope. A focused test may take days, while larger systems often need several weeks.
Cost depends on what needs testing and how complex the system is. We provide a tailored quote after reviewing your scope.